Aortic Insufficiency, Aortic-Stenosis, Degenerative Valve Disease, Transcatheter Aortic Valve Replacement (TAVR)
Conditions
Keywords
TAVR, SAPIEN 3 Ultra RESILIA Valve, S3UR, TAVI, Aortic Stenosis
Brief summary
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Detailed description
Transcatheter aortic valve replacement (TAVI) has become the gold standard treatment for moderate-to-high risk elderly patients with severe symptomatic aortic stenosis. Based on the results of randomized trials including low risk patients, this treatment has been progressively applied to younger (in the sixties and seventies) patients with a low co-morbidity burden. Life expectancy in this group is expected to extend beyond 5 years from intervention in the vast majority of patients, and beyond 10 years in a high proportion. Thus, the issue of valve durability has become one of the most important aspects in the TAVI field in recent years. To date, the rates of bioprosthetic valve failure at 8-10 years after TAVI have been consistently \<10%, but some studies have shown some degree of valve structural degeneration in close to one third of the patients at 8-year follow-up. This subclinical valve degeneration before the 10-year follow-up landmark would represent the initial step in the process of bioprosthetic valve failure, and further valve degeneration leading to clinical symptoms is likely to occur in a significant proportion of these cases. This prospective registry will evaluate the clinical outcomes and the valve performance of the SAPIEN 3 Ultra RESILIA valve over 10 years.
Interventions
PROCEDURETranscatheter aortic valve (S3UR) replacement (TAVR)
Elective transfemoral TAVi procedure with S3UR valve.
Sponsors
Institut für Pharmakologie und Präventive Medizin
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) * Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve * Patient is willing to attend the follow-up visits up to 10 years at the center
Exclusion criteria
* Lack of written informed consent * Emergency procedure * Pregnancy at time of TAVI Critieria for long-term observation (1y-10y): * Technical success at exit from procedure room (VARC-3): * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication * Absence of the following severe procedural and in-hospital complications (VARC-3 definitions): * All stroke * Bleeding type 3-4 * Myocardial infarction * Need for a second valve * Valve embolization * Coronary obstruction * Annular rupture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Safety | 1-3 months | Early safety acc. to VARC-3 |
| Device Success | 1-3 months | Device Success acc. to VARC-3 |
| Bioprosthetic Valve Failure | 3-5 years | Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operations/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3)) |
| Structural Valve Deterioration | 9-10 years | Structural Valve Deterioration ≥ stage 2 (VARC-3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Valve Performance | All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year) | * Prosthetic valve regurgitation including paravalvular regurgitation * Mean transvalvular gradient * Max transvalvular gradient * Effective orifice area |
| Bioprosthetic Valve Failure | All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year) | Bioprosthetic Valve Failure acc. to VARC-3 |
| Bioprosthetic Valve Dysfunction | All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year) | BVD acc. to VARC-3 |
| Patient reported outcomes | 1-3month, 1+3year Follow Up compared to BL | Patient reported outcomes using TASQ questionnaire and EQ-5D questionnaire |
| Cumulated incidence rate BVD or BVF | Up to 10 years | Cumulated incidence rate (per 100 patient-years) of bioprosthetic valve dysfunction (stage 2 or 3) OR bioprosthetic valve failure up to 10-year follow-up |
| Clinical Events | All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year) | Clinical events (mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization) |
| Hemodynamic valve deterioration stage 2 and 3 (VARC-3) | All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year) | HVD stage 2 and 3 according to VARC-3 Criteria (moderate and severe HVD). |
Countries
Germany
Contacts
CONTACTClaudia Lüske, PhD
CONTACTBeate Botta, PhD
PRINCIPAL_INVESTIGATORTanja Rudolph, Prof.
Heart and Diabetes Center North Rhine-Westphalia University Hospital of the Ruhr University Bochum
PRINCIPAL_INVESTIGATORMichael Joner, Prof
German Heart Center
Outcome results
None listed